Texas Lawsuit Seeks to Take at-Home Abortion Pills Off the Market Nationwide
Both sides of the abortion issue are waiting for a federal judge in Texas to rule on a lawsuit that could force the FDA to withdraw chemical abortion pills from the market.
This case follows the FDA's decision to expand access to the two-part drug regimen, allowing doctors to prescribe it via telehealth appointments for women to receive the abortion-inducing pills through the mail.
The Texas lawsuit claims mifepristone, the first of the two drugs taken to induce abortion, is not as safe as advertised and should not have received FDA approval back in 2000.
These chemical procedures currently account for more than 50% of all abortions in the United States. For many years, the FDA sought to expand access to the two-part at-home pill regimen even though a number of doctors and medical organizations question its safety and its approval more than two decades ago.
"From approval and then every time the FDA has loosened its restrictions, it has gone against its own rules to do so," Dr. Ingrid Skop from the Charlotte Lozier Institute told CBN News.
Dr. Skop says it was initially approved under a category called "subpart h" which is for drugs that treat life-threatening illnesses.
"Of course pregnancy in almost every case is not a life-threatening illness, and there already were surgical abortions that were available, so this did not add anything new," explained Dr. Skop. "In fact, studies since that time have shown us that women have four times as many complications after chemical abortions, so they added a drug that was subpar compared to what was already available."
The FDA first approved mifepristone to terminate a pregnancy through seven weeks gestation in 2000 and then extended it through ten weeks gestation in 2016. Skop says a third of women who have chemical abortions are under 18, but claims the FDA didn't conduct a study on pediatric populations during the approval process.
"The FDA's required to do pediatric studies but they just waived that requirement without explanation," says Skop.
She also argues women who take abortion-inducing pills are not adequately prepared for what comes next.
"This is a very difficult process for women, they bleed a lot, they essentially, it's like labor, they have a lot of pain," said Skop. "Often when they deliver the pregnancy they will see their unborn or their child in the toilet and he's about at 8 weeks, he's about the size and shape of a gummy bear, he's clearly identifiable as a human being."
One in twenty women have a complication from chemical abortions, and Skop says she treated one of these women just last month.
"In this woman's case she bled all the way back to Texas from California, bled for another two months, and then finally came to my emergency room where I was able to do a surgery and remove the dead tissue that had been sitting there for two months," recalled Skop.
Last January, the FDA declared that abortion pills are safe enough to be prescribed through telehealth visits.
"The industry, as far as chemical abortion goes, tells them it's safer than Tylenol or a shot of penicillin, so when they do have a complication, if they're one in 20 women that need surgery, they are shocked and they feel that they've been misled," said Skop.
The FDA also cleared the way for retail pharmacies like CVS and Walgreens to provide the medication for the first time.
"We have spent so long in this country trying to get drugs that take life off of the streets and now our federal government has said 'well, it can be sold at your local pharmacy,'" said Brent Leatherwood from the Ethics and Religious Liberty Commission. "That is a decision we vehemently disagree with."
Leatherwood says right out of the gate, many big pharmacy chains declared they'll sell the pill.
"We, our team, immediately we sent a letter to those CEO's of those pharmacies to say that we disagree with this decision and would ask you to please reconsider because a pharmacy should be about care and helping to extend life, not to end it," Leatherwood told CBN News.
Abortion advocates in West Virginia and North Carolina, where state laws restrict use of chemical abortions, have filed lawsuits claiming federal rules should prevail when it comes to setting drug standards.
This is likely just the beginning of legal battles surrounding access to chemical abortions. Multiple states are pursuing laws that would either ban the sale of these abortion-inducing pills or stop women from accessing them without first visiting a doctor in person.